The following data is part of a premarket notification filed by Viora Ltd. with the FDA for Viora V-total.
| Device ID | K133837 |
| 510k Number | K133837 |
| Device Name: | VIORA V-TOTAL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VIORA LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy VIORA LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-18 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016746426 | K133837 | 000 |
| 07290016746129 | K133837 | 000 |
| 07290016746112 | K133837 | 000 |
| 07290016746105 | K133837 | 000 |
| 07290016746099 | K133837 | 000 |
| 07290016746082 | K133837 | 000 |
| 07290016746075 | K133837 | 000 |
| 07290016746068 | K133837 | 000 |
| 07290016746051 | K133837 | 000 |
| 07290016746044 | K133837 | 000 |
| 07290016746037 | K133837 | 000 |
| 07290016746136 | K133837 | 000 |
| 07290016746143 | K133837 | 000 |
| 07290016746150 | K133837 | 000 |
| 07290016746280 | K133837 | 000 |
| 07290016746242 | K133837 | 000 |
| 07290016746235 | K133837 | 000 |
| 07290016746228 | K133837 | 000 |
| 07290016746211 | K133837 | 000 |
| 07290016746204 | K133837 | 000 |
| 07290016746198 | K133837 | 000 |
| 07290016746181 | K133837 | 000 |
| 07290016746174 | K133837 | 000 |
| 07290016746167 | K133837 | 000 |
| 07290016746006 | K133837 | 000 |